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FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant GMP violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
Drugmakers should upgrade their quality assurance systems to quickly identify and fix any manufacturing problems that could spiral into a shortage, according to a wide-ranging plan to address shortfalls in drug supplies. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
Injectable sterile drug manufacturer Pharmaceutics International received a Form 483 for its failure to adequately investigate particulates in products and conducting design inputs for its combination product. Read More
Agila Specialties failed to conduct complete investigations into customer complaints, forcing the FDA to give the Indian manufacturer with a Form 483. Read More
Identical results on different batch tests and other data integrity problems resulted in a Form 483 for Chinese active pharmaceutical ingredient (API) manufacturer Changzhou Qianhong Bio-pharma. Read More
India’s national drugs authority is again surveying pharmacists and testing drug samples in an effort to better grasp the extent of the country’s counterfeit and substandard drugs problem. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
The FDA unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More